Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

Center for International Health and Development

Status and phase

Completed

Phase 4

Conditions

Prematurity

Placental Malaria Infection

Neonatal Deaths

Stillbirth

HIV Infections

Treatments

Drug: Sulfadoxine-pyrimethamine (Fansidar)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00270530

S1954-21/22-2

Details and patient eligibility

About

Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.

Full description

Primary Objectives

To compare the efficacy of IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on the:

Prevalence of placental malaria infection
Prevalence of maternal peripheral parasitemia

Secondary objectives

To compare IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on:

Birth weight, including the proportion of LBW infants
Incidence of prematurity
Neonatal and fetal death and third trimester stillbirth
Incidence of neonatal jaundice
Third trimester anemia
Third trimester severe anemia
Proportion of mothers who develop symptomatic malaria during the course of pregnancy

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
Residence within the catchment area of the health facility
Willing to deliver at the health facility
Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
Willing to provide written informed consent
Aged 18 years and above

Exclusion criteria

Severe anemia (Hb < 6 g/dL)
History of allergic reactions to sulfa drugs
History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization
Any significant presenting illness that requires hospitalization
Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area
Prior enrollment in the study or concurrent enrollment in another study